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临床试验/NCT04269863
NCT04269863Unknown不适用

Personalizing Antiplatelet Therapy in Peripheral Arterial Disease Patients

Unity Health Toronto0 个研究点目标入组 150 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
150
主要终点
PAD disease progression

研究概览

简要总结

Antiplatelet therapies are important to decrease the morbidity and mortality associated with Peripheral Arterial Disease (PAD) through the prevention of thrombus formation. Aspirin (ASA) is a readily available and affordable antiplatelet medication that can help reduce adverse cardiovascular events by up to 25%. However, 25-60% of PAD patients are "ASA insensitive" having a lower than normal ability to inhibit platelet aggregation after standard aspirin dosing. In a previous study conducted by our lab, we were able to demonstrate a methodology for personalizing antiplatelet therapy using two platelet function tests, Platelet Function Analyzer-100 (PFA 100) and Light Transmission Aggregometry (LTA). To investigate this methodology further, we would like to conduct a pilot study on two cohorts of patients, one population continuing with their current medications (81mg ASA), and a second group who will get personalized antiplatelet therapy using our methodology (81-325mg ASA). In this study, 150 PAD patients taking 81mg Aspirin therapy presenting for clinical follow-up, or in-patient intervention, in vascular clinics or the emergency room, will be recruited to our study. 75 patients will be randomly assigned undergo platelet analysis using PFA-200 and LTA, and will have their antiplatelet therapy personalized. Patients will then be followed up in order to see if the patients with personalized therapy have better platelet inhibition. This study will allow us to help personalize antiplatelet therapy in PAD patients, allowing for better patient outcomes and decreased adverse cardiovascular events.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-reported intake of either 81 mg of aspirin per day for 3 or more days
  • Diagnosed with peripheral arterial disease

排除标准

  • Alcohol ingestion 24 hours prior to blood draw
  • Patients receiving glycoprotein (GP) IIb/IIIa antagonists
  • Ingestion of a non steroidal anti-inflammatory drug 3 days prior to blood draw
  • History of bleeding disorders
  • Gastrointestinal bleeding
  • Hemorrhagic stroke
  • Allergy to aspirin or ticagrelor
  • Pregnancy, thrombocytopenia anmia or leukopenia

研究组 & 干预措施

Control Group

Experimental

This group of 75 patients is the control group that will be receiving the standard lowest dosage of 81mg aspirin.

干预措施: Aspirin (Drug)

Treatment Group

Experimental

This group of 75 participants is the treatment group that will be receiving personalized aspirin dosage between 81mg-325mg (within standard clinical recommendations), which will be determined based on platelet analysis via PFA-200.

干预措施: Aspirin (Drug)

结局指标

主要结局

PAD disease progression

时间窗: 1 year

Using lower limb arterial imaging (doppler ultra sound), and ankle brachial index, patients will be categorized based on Ruthorford Classification of chronic limb ischemia. Progression of PAD will be considered decrease in ABI, and progression to more sever forms according to the Rutherford classification.

development of Critical limb ischemia

时间窗: 1 year

Critical limb ischemia will considered as those patients who have progressed from claudication to night paint, rest pain, and/or tissue loss.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad

Vascular Surgeon

Unity Health Toronto

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